1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
Inspection Record
Hydrx Farms Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
The handling of rejected materials and products was inadequate.
3Equipment and facility
The education, experience, and/or oversight of the individual in charge of the manufacturing department was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The maintenance of personnel records was inadequate.
4Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
5Equipment and facility
The handling of standard operating procedures for good manufacturing practices was inadequate. The maintenance of records was inadequate.
6Other quality system
The purified water system was inadequate with the potential for water not meeting the appropriate requirements for chemical and microbial purity.
7Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-04-15. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
